Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20^™ neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour. Read more.

Source: BusinessWire, January 31, 2023

Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System

Source: Business Wire, March 7, 2022

Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

Valencia Technologies Corporation, a privately held company, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin^® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable safety profile demonstrated in the eCoin^® pivotal trial. The company also announced the publication of these results in the Journal of Urology^®, the official journal of the American Urological Association. Read more.

Source: PRNewswire, March 2, 2022

InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control

Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention. The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but it is a rechargeable device with an expected longevity of about 15 years. This is made possible partially thanks to so-called Overdrive technology that lets the battery maintain almost its full capacity to recharge throughout its working life. Read more.

Source: Medgadget, January 13, 2020

Medtronic Announces FDA Submission for InterStim™ Micro Neurostimulator and SureScan™ MRI Leads

Medtronic plc (MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan™ leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval. Read more.

Source: Globe Newswire, October 7, 2019

InterStim Incontinence and Bladder Control Implant Now Controlled via App

Medtronic won FDA approval to introduce the InterStim smart programmer to control the company’s InterStim neurostimulation system used to manage overactive bladder, bowel incontinence, and some types of urinary retention. The InterStim system delivers sacral neuromodulation therapy via an implant that looks similar to a cardiac pacemaker. Read more.

Medgadget, December 17, 2018